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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00093574 |
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's lymphocytes to kill kidney cancer cells. Combining biological therapy with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cellular adoptive immunotherapy together with interleukin-2 works in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Biological: aldesleukin Biological: filgrastim Biological: therapeutic autologous lymphocytes Biological: therapeutic tumor infiltrating lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study in Metastatic Renal Cell Cancer Using Cultured, Tumor-Reactive Lymphocytes and Interleukin-2 |
Estimated Enrollment: | 100 |
Study Start Date: | September 2004 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
OUTLINE: Tumor-reactive T-lymphocytes are isolated from tumor-infiltrating lymphocytes, peripheral blood mononuclear cells, or lymph nodes and expanded in vitro. Several months later, eligible patients receive cultured T-lymphocytes IV over 10-20 minutes followed by interleukin-2 (IL-2) IV over 15 minutes every 8 hours for up to 12 doses. Approximately 1 month later, patients are evaluated. Responding patients continue to receive T-lymphocytes and IL-2 until the cells are used up in the absence of disease progression or unacceptable toxicity. Non-responding patients receive a preparative regimen comprised of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1. Beginning on day 0, patients receive the cultured T-lymphocytes and IL-2 as before. They also receive filgrastim (GM-CSF) subcutaneously daily until blood counts recover.
Treatment may be repeated once approximately 1 month later in the absence of unacceptable toxicity or disease progression AND provided there are an adequate number of cells.
PROJECTED ACCRUAL: A total of 29-100 patients (a maximum of 29 to be treated) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of renal cell carcinoma (RCC)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | James C. Yang, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000389227, NCI-04-C-0277, NCI-5774 |
Study First Received: | October 6, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00093574 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage IV renal cell cancer recurrent renal cell cancer |
Antimetabolites Urinary Tract Neoplasm Immunologic Factors Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Renal Cancer Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Kidney Diseases Analgesics Alkylating Agents Kidney Cancer Anti-HIV Agents |
Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Recurrence Carcinoma Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Carcinoma, Renal Cell Peripheral Nervous System Agents Fludarabine Antineoplastic Agents, Alkylating Adenocarcinoma Antirheumatic Agents Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Neoplasms by Site Anti-Retroviral Agents Urologic Diseases Sensory System Agents Kidney Neoplasms |
Therapeutic Uses Analgesics Kidney Diseases Alkylating Agents Anti-HIV Agents Neoplasms by Histologic Type Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Aldesleukin Analgesics, Non-Narcotic Interleukin-2 |